Status:
COMPLETED
Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Lead Sponsor:
Rebecca Cox
Collaborating Sponsors:
Haukeland University Hospital
European Commission
Conditions:
Influenza
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated locally and system...
Eligibility Criteria
Inclusion
- Healthy volunteers (as concluded from the medical history, physical examination, and clinical judgment) aged 19 to 50 years old
- Females using a reliable method of contraception (from 4 weeks prior to the first vaccination until 4 weeks after the second vaccination) and a negative urine pregnancy test will be required before administration of each dose of vaccine
- Signed informed consent
- Subjects able to understand and comply with the study protocol and complete the Adverse Event Form
- Subjects able to attend the scheduled visits
- Subjects with normal pre-screening values. If a subjects prescreening samples lie outside the reference values he/she will only be included in the study based upon the medical evaluation of the clinical investigator
Exclusion
- Persons with a history of anaphylaxis or serious reactions to any vaccine
- Persons with known hypersensitivity to any of the vaccine components
- Persons who have had a temperature \>38oC during the previous 72 hours
- Persons who have had an acute respiratory infection during the last 7 days
- Women who are pregnant or breast-feeding
- Persons with chronic illness at any stage that could interfere with trial conduct or compliance
- Persons who have received blood products or immunoglobulins parenterally during the previous 3 months
- Persons who have been vaccinated with any vaccine during the 4 weeks preceding the first trial vaccination
- Persons with known or suspected immunosuppressive disease or who use systemic immunosuppressive drugs
- Persons taking immunostimulant therapy
- Persons involved in another clinical trial during the last month.
- Suspected non-compliance
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00868218
Start Date
March 1 2009
End Date
November 1 2013
Last Update
November 18 2019
Active Locations (1)
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1
Haukeland Univeristy Hospital
Bergen, Norway, N-5021